FDA qualification of a new Medical Device Development Tool

U.S. Food and Drug Administration sent this bulletin at 04/03/2024 03:16 PM EDT

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U.S. Food and Drug Administration, Center for Devices and Radiological Health

FDA qualifies Lethal Arrhythmia Database as an MDDT

The FDA is announcing the qualification of a new tool for the evaluation of lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems (UCSF LAD MDDT), through the Medical Device Development Tools (MDDT) program.

The University of California San Francisco (UCSF) Lethal Arrhythmia Database (LAD) Medical Device Development Tool (MDDT) version 1.0.0 is designed to:

Provide a comprehensive set of data designed for the evaluation of algorithms utilized in hospital monitoring systems
Test and report the performance of computerized methods to detect lethal cardiac arrhythmias in patient monitoring systems
Assesses algorithms for detecting three lethal cardiac arrhythmias (asystole, ventricular tachycardia, and ventricular fibrillation) in adult hospital patients across three ICU settings (Cardiac, Medical/Surgical, and Neurological).

Qualified Medical Device Development Tools

Questions?

If you have questions about CDRH’s qualification of Medical Device Development tools, contact the MDDT program at mddt@fda.hhs.gov.

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